Restricting Flavors in ENDS Could Have Repercussions Beyond Youths’ Use

In January of this year, the Food and Drug Administration (FDA) issued a guidance (“Guidance”) prioritizing removal from the market of flavored, cartridge-based electronic nicotine delivery systems (ENDS), as well as products that the agency deems to target underage youths. The FDA reasoned that this Guidance was a necessary response to youths’ use of ENDS and a 2019 outbreak of vaping-related lung disease (EVALI), although the latter was confirmed to be associated with products containing THC (tetrahydrocannabinol, the principal psychoactive constituent of cannabis). This approach appears to be a stark departure from former FDA commissioner Scott Gottlieb’s 2017 views that ENDS were a helpful step down the risk continuum.

Smart tobacco harm reduction regulation should be comprehensive with respect to the nicotine products it addresses and should aim to move consumers down the risk continuum toward use of reduced risk products. Bans decelerate harm reduction and renormalize cigarette use. Worryingly, a number of countries have already veered down the path of prohibition. Existing regulatory actions include the following: ENDS flavor restrictions in the United States, a ban on snus in the European Union (although the FDA has recognizing this product as less risky than cigarettes), and complete bans on noncombustible nicotine products in several Asian and South American countries.

In April 2019, US news outlets began reporting cases of lung damage—and sometimes death—in people using vaping products. No similar issues were reported anywhere else in the world. Eventually, FDA and Centers for Disease Control and Prevention (CDC) investigations clarified that these illnesses were linked to illicit products containing THC and not ENDS.¹ However, media attention and many tobacco control nongovernmental organization activists exacerbated the public’s misperception that ENDS are more harmful than smoking—a case of alarmism that may deter many of the United States’ more than 30 million smokers from switching to less risky products. As the Guidance does not address THC products, it does little to prevent future cases of EVALI. Its issuance, however, will continue to provide governments a pretext to limit or ban alternative nicotine products, thus missing a potentially huge tobacco harm reduction opportunity and denying smokers options that could better their health.

The Guidance’s focus on flavored ENDS fails to address recent CDC data, which indicates that the major drivers of youths’ ENDS use are curiosity and peer influence—not flavors.² There are potentially more effective approaches to tackle youth vaping, such as enhanced marketing and access restrictions and improved enforcement of existing regulations.³ Notably, many adults have used flavored ENDS to transition away from smoking.⁴ Removing this “off-ramp” could prevent additional adults from quitting and could prompt some former smokers to resume their old habit.⁵ The prohibition of popular flavored ENDS could also lead to the emergence of an illicit market, with potentially deadly consequences similar to the EVALI case.

This Guidance does not address the mounting evidence that ENDS are likely to be significantly less harmful than combusted cigarettes,⁶ but it does reduce the availability of products for smokers seeking a way to quit. Countries where alternative, reduced risk products are widely available—including ENDS in the United Kingdom, heated tobacco in Japan, and snus in Sweden—have seen rapid reductions in smoking prevalence. By contrast, bans on ENDS or oral nicotine will ultimately limit the avenues to quit and push consumers to the black market.

Ultimately the greatest health impact any policy or regulation can have is to substantially reduce cigarette use. This is possible through a combination of risk-proportionate regulation, public-facing messages about the limited risks of nicotine, robust scientific evaluation of available data, and incentives to develop more effective cessation options.